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# Defender Pharma NDA for Scopolamine Gel
- URL: https://www.fdaweb.com/defender-pharma-nda-for-scopolamine-gel/
- Published: 2023-07-26T12:00:00.000Z
- Updated: 2026-09-14T18:46:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154965

Defender Pharmaceuticals has submitted an NDA for its intranasally administered scopolamine gel (DPI-386 Nasal Gel) for preventing motion-caused nausea and vomiting in adults. Scopolamine has been marketed for decades in a transdermal patch formulation and Defender believes its unique intranasal gel formulation offers the ability to bring faster and effective nausea relief.

The submission is based on data from the company’s recently completed Phase 3 study of DPI-386 Nasal Gel that had a primary endpoint complete response assessment in reducing the proportion of participants who reported no vomiting and who did not request rescue treatment compared to placebo. Defender says that it expects a user fee review action date in the first quarter of 2024.

“Positive results demonstrated that the proportion of participants in the DPI-386 treatment arm who did not report vomiting and did not request rescue treatment was significantly greater (p<0.0001) than participants receiving placebo,” Defender says. “Reduction in nausea including moderate to severe nausea with DPI-386 was also demonstrated to be statistically significant relative to placebo (p<0.0001) during the entire trial period,” it adds.